A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

Overview

• TITAN was a double-blind phase 3 trial in men with metastatic castration-sensitive prostate cancer, randomised to apalutamide 240 mg daily or placebo added to androgen deprivation. Previous treatment for localised disease and previous docetaxel were allowed. Median age was 68; 16.4 percent had had prostatectomy or radiotherapy for localised disease and 10.7 percent previous docetaxel; 62.7 percent had high-volume and 37.3 percent low-volume disease. At the first interim analysis, median follow-up 22.7 months, both primary endpoints were met. Grade 3 or 4 adverse events occurred in 42.2 percent on apalutamide and 40.8 percent on placebo, with rash more common on apalutamide (New England Journal of Medicine 2019).
• In England NICE TA741 recommends apalutamide with androgen deprivation for hormone-sensitive metastatic prostate cancer only if docetaxel is not suitable. NICE TA1109 makes the same restriction for darolutamide with androgen deprivation and instructs prescribers to use the least expensive of the suitable options, which includes apalutamide, taking account of administration costs, dosages, price per dose and commercial arrangements.